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FDA 510(k)

Optimus ALIF System

K-Number: K160291 · 2016-02-18

ApplicantAmendia, Inc.
Decision Date2016-02-18
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Optimus ALIF System is the device name listed in this FDA 510(k) record. The listed applicant is Amendia, Inc.. It received FDA 510(k) clearance on 2016-02-18 under 510(k) number K160291. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Optimus ALIF System?

Optimus ALIF System is a medical device that received FDA 510(k) clearance on 2016-02-18. The listed applicant is Amendia, Inc.. The 510(k) number is K160291.

When did Optimus ALIF System receive FDA 510(k) clearance?

Optimus ALIF System received FDA 510(k) clearance on 2016-02-18, under 510(k) number K160291.

Who is the listed applicant for Optimus ALIF System?

The FDA 510(k) record lists Amendia, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optimus ALIF System?

The FDA product code for Optimus ALIF System is OVD.

Other records listing Amendia, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160924Amendia Interbody Fusion DevicesK161842Overwatch Spine SystemK152920Savannah-T® Pedicle Screw SystemK153152Syzygy Stabilization SystemK152972Amendia Stand-Alone Cervical SystemK151310Amendia Interbody Fusion Devices

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Related Devices (Code: OVD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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